The purpose and effect of the proposed rule is to set forth the parameters under which an entity permitted under Chapter 499, F.S., Part III, may distribute emergency use medical oxygen.

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.027Distribution of Emergency Use Medical Oxygen

PURPOSE AND EFFECT: The purpose and effect of the proposed rule is to set forth the parameters under which an entity permitted under Chapter 499, F.S., Part III, may distribute emergency use medical oxygen.

SUMMARY: The subject area to be addressed in this rule is the distribution of medical oxygen for emergency use by persons authorized to receive emergency use oxygen.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The Economic Review conducted by the agency.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 499.85 FS.

LAW IMPLEMENTED: 499.83, 499.85, 499.86, 499.89, 499.90 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Dinah Greene, Division of Drugs, Devices and Cosmetics, Department of Business and Professional Regulation, 1940 N. Monroe Street, Suite 26A, Tallahassee, Florida 32399-1047, [e-mail], [phone].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

61N-1.027 Distribution of Emergency Use Medical Oxygen.

A medical oxygen retail establishment permitted under Chapter 499, F.S., Part III, shall not engage in the distribution of emergency use medical oxygen unless it meets the following requirements:

(1) The permittee’s permit is current;

(2) The permittee has a policy and procedure in place governing its distribution of emergency use medical oxygen that complies with the requirements for wholesale distributors set forth in Section 499.90, F.S.;

(3) The permittee creates, contemporaneously and no later than 24 hours after the distribution of emergency use medical oxygen to persons authorized to receive emergency use oxygen, records pertaining to the distribution that comply with the recordkeeping requirements set forth in Section 499.89, F.S.; and

(4) The distribution of the emergency use medical oxygen does not occur between the parties for a time period of more than fourteen (14) calendar days.

Rulemaking Authority 499.85 FS. Law Implemented 499.83, 499.85, 499.86, 499.89, 499.90 F.S. History-New___________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Reginald D. Dixon, Division Director

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Ken Lawson, Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: April 10, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: April 9, 2015